COPD Patients
Conditions
Brief summary
This is a random, single blind, positive control, crossover design clinical study to evaluate the pharmacokinetics and pharmacodynamics of HSK39004 inhalation suspension in COPD patients
Interventions
HSK39004 inhalation suspension , Inhale through the mouth, 3mg each time, twice a day; Ohtuvayre inhalation suspension, Inhale through the mouth, 3mg each time, twice a day
Sponsors
Haisco Pharmaceutical Group Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* During the screening visit (Visit 1), the age range is 40 to 80 years (including the threshold value), and gender is not restricted; * The subjects with chronic obstructive pulmonary disease (COPD) as per the GOLD 2025 diagnostic criteria, and the symptoms before screening were consistent with COPD for at least 1 year \[GOLD 2025 standard: the subjects have chronic respiratory symptoms such as shortness of breath, chronic cough or expectoration, and/or have a history of exposure to risk factors, and the pulmonary function test results show: the forced expiratory volume in one second (FEV1) after using bronchodilators / forced vital capacity (FVC) \<0.7\]; * During the screening visit (Visit 1):· FEV1/FVC after using bronchodilators is \<0.7;· 30% of the expected value ≤ FEV1 after using bronchodilators \< 80% of the expected value; * COPD stable within 4 weeks prior to screening period (Visit 1); * During the screening period and treatment period, COPD drugs prohibited by the protocol (except for salbutamol inhalation aerosol as a rescue drug) can be discontinued; * Current smokers with a smoking quantity of ≥ 10 packs per year (smoking index (pack years) = daily smoking quantity (packs) × time (years), 1 pack = 20 cigarettes), or quit smoking for more than 6 months, or those with a history of exposure to other risk factors; * Participants voluntarily sign the informed consent form；
Exclusion criteria
* Have a history of life-threatening COPD, including being admitted to the intensive care unit and/or requiring intubation; * Have received treatment for COPD acute exacerbation for pneumonia within 12 weeks before screening; * Have a history of or currently have severe cardiovascular diseases; * Have type I diabetes or poorly controlled type II diabetes (fasting blood glucose ≥ 10 mmol/L at screening); * Have cancer (in situ cancer that has been cured for more than 5 years, skin squamous cell carcinoma and basal cell carcinoma, etc., except for subjects with suspected malignant tumors or undetermined tumors); * Combine other severe unstable kidney, nervous system, endocrine diseases, thyroid diseases, urinary system, ophthalmic diseases, immune system, mental system, gastrointestinal, liver or blood system disease/abnormal history, as determined by the investigator, participation in this study may pose risks to the subjects or affect the analysis of research results; * During the screening period (visit 1), the investigator determines that the laboratory tests of the subjects show clinically significant abnormalities that may pose risks to the subjects; * Allergy to HSK39004 inhalation powder or salbutamol or any known components in the administration system ; 8. Before the pulmonary function test during the screening (visit 1), any prohibited drugs in the protocol were used; * During the screening period, there were clinically significant abnormalities in the 12 lead electrocardiogram that were determined by the researchers to be potentially risky for the subjects; * Had major surgery (requiring general anesthesia) within 6 weeks before screening, not fully recovered at the time of screening, or planned to undergo surgery before the end of the study; * Pregnant or lactating women, or female subjects with positive pregnancy test results; * Researchers determine other subjects who are not suitable to participate.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Cmax after single administrations | [Time Frame: From the start of administration to 12 hours post-dose] | The Cmax of HSK39004 in plasma |
| The Css(max) after multiple administrations (steady state) | [Time Frame: From the start of administration to 7 days post-dose] | The Css(max) of HSK39004 in plasma |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The ΔFEV1 AUC0-12h | [Time Frame: From the start of administration to 12 hours post-dose on Day1 and Day7] | The area under the curve of FEV1 change from baseline from 0 to 12 hours after administration |
| AEs | [Time Frame: From the time of signing ICF to the end of follow-up，up to 7 days after the last administration] | The incidence and severity of AEs |
Countries
China
Outcome results
None listed